Kornimate/medical-research-clean huggingface dataset:
prevention and pharmacological management of cardiac adverse drug reactions induced by drugs used in oncology.

Conditions: Cardio-oncology

Summary: recently, the medical management of cancer patients has considerably improved the prognosis of these patients and today some cancers are becoming "chronic diseases". as a result, new adverse effects (aes) are observed, particularly cardiac. these "new" cardiac aes are the consequence of a significant increase in patients life expectancy (delayed aes not previously seen) but also the use of new pharmacological classes of anticancer drugs such as kinase inhibitors. the incidence of these cardiac aes varies according to the patient profile and the anticancer molecules used, but their impact on the morbidity and mortality of the patients is significant. in this context, we started at the university hospital of caen normandy in september 2017 a cardio-oncology program entitled "prevention and pharmacological management of cardiac adverse effects induced by drugs used in oncology" (picaro program). this program involves the pharmacology department (opening of a dedicated consultation), the cardiology department (opening of a dedicated ultrasound consultation), vascular medicine departement (opening of a dedicated consultation) and the oncology federation. this program aims to be regional in the future. we therefore propose to build a cohort backed up to the picaro program to assess the regional impact of cardiac aes of anticancer drugs and thus to be better able to specify the number of aes, the incidence and regional prevalence of these drugs. . the constitution of this cohort is only the first step towards the constitution in the near future (2 years) of an observatory and then a regional registry of cardiac aes induced by anticancer drugs. the objectives associated with the establishment of such a registry would be to reduce the number of cardiac aes, the hospitalizations caused by these aes, a better information of health professionals and patients, an improvement in the screening of patients at risk, all coming back in the context of health, clinical, epidemiological and pharmacological surveillance.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years, * attents of cancer, * addressed for the first time to one of the picaro program consultations at the university hospital of caen normandy, * written informed consent, * patient beneficiary of the french social insurance. exclusion criteria: * minor and major protected patients * pregnant or nursing women * patient already included in the picaro cohort * patients under guardianship, curatorship, safeguard of justice or legal protection.
genetics of airway responsiveness and lung function

Conditions: Asthma; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: to perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (copd) in a chinese population.

design narrative: airway responsiveness and lung function, endpoints with a strong genetic basis, are central to the obstructive airway diseases (asthma and copd). in contrast, the dissection of the underlying genes requires unique sample resources, accurate and comprehensive phenotyping, and an efficient study design. to address to this three-pronged challenge, a genomic screen brought together a large, homogenous, mostly untreated sample from anhui, china, a wealth of expertise in asthma phenotypes, and a potent study design based on extreme discordant sib pairs. since this approach utilized an extant asthmatic family population, no support for data collection was required. the primary focus of the study was two intermediate phenotypes related to asthma and copd: airway responsiveness (characterized by increased responsiveness to histamine methacholine or other nonspecific agonists and measured by the slope of the dose response relationship) and forced expiratory volume in 1 second (fev1). since both traits are continuous, the appropriate study design considered only siblings with extremely discordant phenotypes. for many studies, this strategy was not feasible due to the thousands of families that must be phenotyped to identify a sample of such siblings. the plan was to utilize the organization of a well-established network in china to collect 150 extreme discordant sib pairs of each intermediate phenotype. for airway responsiveness, the estimated power from this sample, equivalent to roughly 600 concordant sib pairs, was intended to surpass the power of all existing studies, including the u.s. collaborative study on the genetics of asthma. further, with similar power, this was the first study to test for linkage to fev1. moreover, to further augment power, potential phenotypic heterogeneity was reduced by stratifying the analyses by total and specific serum ige levels, skin test reactivity, peripheral blood eosinophilia, respiratory symptoms, age, gender, bronchodilator response, and cigarette smoking. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
optiflow thrive for delivery of oxygen to patients during total intravenous anesthesia while undergoing radiology procedures

Conditions: Obstructive Sleep Apnea

Summary: this trial studies how well optiflow thrive works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. the optiflow thrive is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. the optiflow thrive device may improve oxygen delivery and reduce breathing complications.

primary objective: i. to investigate the performance of optiflow thrive relative to standard non-rebreathers in patients with high risk of difficult airway management undergoing interventional radiology procedures for the planning of future clinical studies. secondary objective: i. to describe the episodes of hypoxia (defined by peripheral capillary oxygen saturation \[spo2\] less than or equal to 92%) and the episodes of airway support which include: jaw thrust, chin lift or insertion of an airway supporting device, such as oral/nasal airway or supra airway device in order to recover the level of oxygenation above 92% associated with optiflow thrive. outline: patients are randomized to 1 of 2 arms. arm i: patients receive 100% oxygen at a high flow rate via optiflow thrive over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure. arm ii: patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure. after completion of study, patients are followed up at 15 minutes.

Eligibility criteria:
inclusion criteria: * signed consent for the study * patients with an spo2 greater than or equal to 95% while breathing room air * patients requiring total intravenous anesthesia (tiva) but not tracheal intubation during the proposed procedure - plus, any of the 2 following criteria: body mass index (bmi) greater than or equal to 32 kg/m\^2, or neck circumference greater than or equal to 43 cm in a male and 41 cm in a female, or has been diagnosed with moderate to severe obstructive sleep apnea (osa) with/without using a continuous positive airway pressure (cpap) device * full course head and neck radiotherapy less than or equal to 6 months (the peak onset time of acute facial and airway edema) exclusion criteria: * significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.) * significant cardiac disease (including history of myocardial infarction \[mi\] with concurrent evidence of ischemic myocardial damage at the event, cardiomyopathy with impaired left ventricular ejection fraction to less than 50% or uncompensated congestive heart failure) * tiva is contraindicate or having a proposed procedure without tiva * endotracheal intubation is required * american society of anesthesiologists (asa) physical status classification 5 * patients who are non-english speaking * emergency procedures
posterior cerebral artery occlusion study

Conditions: Stroke, Acute Ischemic

Summary: for this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment). the electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (ivt), or medical management.

the primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (pca), whether favorable outcome would be superior for evt compared to medically management (mm), inclusive of intravenous thrombolysis (ivt), as measured by: * 90-day modified rankin scale (mrs) ordinal shift or * decrease in nih stroke scale/score (nihss) by two points at 24 hours or at hospital discharge the secondary aims are to evaluate in patients presenting with pca occlusion, other outcome and safety metrics: * 90-day functional independence, mrs 0-2 * 90-day excellent outcome, mrs 0-1 * visual field recovery (none, partial, complete) by 90-days * rate of reperfusion by modified thrombolysis in cerebral infarction (tici) scale grade * any intracranial hemorrhage * symptomatic intracranial hemorrhage * mortality in subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by: * location of occlusion on the pca segment (p1, p2, p3) * nihss strata (0-6, 7-15,\>16) * time from symptom onset to treatment (0 to \<6h vs 6-24h) * posterior circulation (pc) acute stroke prognosis early computed tomography score (aspects) * visual field defect on presentation the investigators hypothesize that greater benefit in outcomes would be seen in evt treated patients with higher nihss, more proximal pca occlusion, higher pc aspects scores, and shorter time from symptom onset to treatment.

Eligibility criteria:
inclusion criteria: * had an ischemic stroke with isolated posterior cerebral artery occlusion (p1, p2, or p3 segments) and was medically managed or managed with evt during the study time period. exclusion criteria: * patient with documented basilar artery occlusion and concomitant pca occlusion * patient with documented basilar artery occlusion, migration with secondary pca occlusion

Keywords: posterior occlusion artery (pca) intravenous thrombolysis (ivt) endovascular therapy (evt) modified rankin scale (mrs)
frequency of oral hygiene

Conditions: Gingivitis; Oral Health

Summary: the purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of gingival health in patients with an adequate method of oral hygiene.

the study was a randomized blinded clinical trial. eligible patients underwent a pre-clinical period in order to eliminate factors that could interfere with the proper plaque control. forty-five non dental students with healthy gingival (maximum 5% of sites showing gingival bleeding) were randomized into four groups according to the frequency of oral hygiene (every 12h, 24h, 48h or 72h). plaque index (pli) and gingival index (gi) were evaluated by two trained examiners at baseline, 15 days and 30 days.

Eligibility criteria:
inclusion criteria: * students of graduate courses at the federal university of santa maria and franciscan university center * a minimum age of 18 years * filling all space interdental papilla * at least 24 teeth * maximum 15% of sites with gingivitis. exclusion criteria: * dental students * pregnant woman * diabetics * smokers * orthodontic equipment * antimicrobial prophylaxis * antibiotic * anti-inflammatory * psychomotor disturbances * periodontitis * pd ≥ 3mm
clinical phenotype and omics study of kcnq2-related epilepsy

Conditions: KCNQ2-related Epilepsy

Summary: the aims of study on kcnq2-related epilepsy: (1) establish phenotype database and sample database of kcnq2-related epilepsy; (2) to establish genotype-phenotype association of kcnq2-related epilepsy; (3) to study the brain network of kcnq2-related epilepsy based on multi-modal brain image and eeg data; (4) to find prognostic biomarkers of kcnq2-related epilepsy based on omics study.

1. participant recruitment: participants are recruited from chinese kcnq2-related epilepsy patients group (http://www.kcnq2.cn/). according to the clinical phenotype, the participants will be divided into benign familial neonatal seizures (bfns) group and developmental and epileptic encephalopathy (dee) group. 2. genotype-phenotype association: electrophysiological detection of kcnq2 mutation will be performed using patch clamp technique in an in vitro cell model. the association between phenotype (such as epileptic phenotype, developmental assessment and drug response) and genotype will be analyzed. 3. brain network analysis: participants who provide informed consent will be scaned by brain magnetic resonance imaging (mri) or positron emission tomography-computed tomography (pet-ct) and monitored by the electroencephalogram (eeg). the brain network of kcnq2-related epilepsy will be analyzed based on multi-modal brain image and eeg between bfns and dee group. 4. omics study: after informed consent, blood, urine and feces samples of participants will be taken. the samples were tested for omics study including proteomics, metabolomics, transcriptomics, to analysis the difference of bfns and dee group.

Eligibility criteria:
inclusion criteria: * kcnq2 mutation was confirmed by wes, panel and other gene tests; * clinically diagnosed as epilepsy; * kcnq2 mutation was identified as pathogenic or possibly pathogenic according to acmg pathogenicity rating standard; * age and gender are not limited; * no abnormal birth history; * informed consent and willingness to follow up exclusion criteria: * patients with kcnq2 mutation without epilepsy; * other possible pathogenic gene mutations except kcnq2; * large cross-gene deletions or duplications including kcnq2; * unable to participate in the study follow-up

Keywords: kcnq2-related epilepsy benign familial neonatal seizures developmental and epileptic encephalopathy genotype-phenotype association brain network omics study
substantivity of oral rinses: comparative study

Conditions: Prevention & Control

Summary: a desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. this work aims to quantitatively determine the substantivity of (i) a single o-cymen-5-ol plus cpc oral rinse, (ii) a, cpc oral rinse and (iii) a o-cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

one of the desirable qualities of mouthrinses is substantivity, which is defined as the persistence capacity of its antimicrobial action over time in the mouth. this is an intrinsic feature of some molecules. such substantivity seems to require the adsorption of the agent on the buccal surfaces and subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic. substantivity is the result of multiple factors controlling or altering adhesion, life period of antimicrobial capabilities, synergisms, antagonisms, and others. in order to improve substantivity and therefore increase antimicrobial effectiveness of cpc, o-cymen-5-ol has recently been proposed to become incorporated to oral rinses. the aim of this work is to quantitatively determine the substantivity of (i) a single o-cymen-5-ol plus cpc oral rinse, (ii) a, cpc oral rinse and (iii) a o-cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

Eligibility criteria:
inclusion criteria: 1. adult age (\>18 y/o) 2. good oral helath status 3. minimum 24 evaluable teeth 4. periodontal pockets ≤3 mm 5. absence of caries \& periodontal haemorrage exclusion criteria: 1. smokers 2. prosthesis or orthodontic devices 3. sjögren syndrome 4. antibiotic treatment in the last three months 5. systemic disease with alteration in the production and/or composition of the saliva

Keywords: mouth rinses substanticity oral infections salivary microbiota
sentimag® intraoperative comparison in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this pivotal study is to provide prospective evidence that the sentimag®/siennaxp® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (slnb) procedure and to summarize measures of product safety and performance.

this is a pivotal, prospective, open label, multicenter, paired comparison of the sentimag® and siennaxp® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. the trial is designed to provide powered evidence that the lymph node detection rate of the sentimag® and siennaxp® system is non-inferior to the standard of care in patients with breast cancer.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (dcis). * subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan. * subjects aged 18 years or more at the time of consent. * subjects with an ecog (eastern cooperative oncology group) performance status of grade 0 - 2. * subject has a clinical negative node status (i.e. t0-3, n0, m0). exclusion criteria: * the subject is pregnant or lactating. * the subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes. * the subject has a known hypersensitivity to isosulfan blue dye. * the subject has participated in another investigational drug study within 30 days of scheduled surgery. * subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment. * subject has had preoperative radiation therapy to the affected breast or axilla. * subject has received a feraheme® (ferumoxytol) injection within the past 6 months. * subject has intolerance or hypersensitivity to iron or dextran compounds or to siennaxp. * subject has an iron overload disease. * subject has pacemaker or other implantable device in the chest wall.

Keywords: breast cancer sentinel lymph node biopsy
computer navigation-assisted surgery for locally advanced and recurrent rectal cancer

Conditions: Rectal Cancer

Summary: the aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (larc) and recurrent (lrrc) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. the investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.

curative treatment of rectal cancer requires surgical removal of the tumour. the key challenge in this surgery is to remove the tumour with free margins - r0 resection. failure to achieve r0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. achieving r0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs. computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. in such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease. with this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. if found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.

Eligibility criteria:
inclusion criteria: * patients with larc or lrrc (either biopsy verified, or demonstrated on mri and confirmed by the mdt decision) * the mdt must deem standard surgical strategy at high risk of resulting in r1/r2 resection and computer-assisted navigation likely to improve the chances of obtaining r0 resection. * written informed consent exclusion criteria: * non-adenocarcinoma malignancies. * unresectable distant metastatic disease or unresectable synchronous other malignancy * patients deemed unfit to participation according to the mdt.

Keywords: surgery, computer-assisted feasibility study
a study of aerobic exercise for patients with bipolar disorder

Conditions: Bipolar Disorder; Cognitive Symptom

Summary: this study will investigate the effects of aerobic exercise on mental states, cognition, bdnf, and long-term outcomes in patients with bipolar disorder.

multiple cognitive impairments are common in patients with bipolar disorder. preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in patients with mood disorders. this randomized controlled trial will investigate short-term (1 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (12 months) effects on decreasing the recurrence rate.

Eligibility criteria:
inclusion criteria: * dsm-iv defined bipolar disorder. * never accept aerobic exercise therapy. * dextromanuality. exclusion criteria: * diagnosed neurological or musculoskeletal disorder/injury, * uncontrolled cardiovascular or metabolic diseases that are not suitable for running * diagnosed hypertension * other diagnosed serious medical conditions that are not suitable for cycling * severe suicidal ideation * mental retardation * currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week

Keywords: neurocognition prognosis aerobic exercise